Facts Of The Case

 The dispute arose in Delhi High Court over Roche’s drug ‘Erlotinib’
that was sold by Roche as TARCEVA.
 Both Roche and Cipla are based on the compound that goes by the
name Erlotinib Hydrochloride.
 In February 2007, Roche after claiming that it had been granted a
patent for ‘Erlotinib’ started selling the drug under the brand name
TARCEVA.
 In January 2008, it was reported that Cipla is planning to launch a
generic version of ‘Erlotinib.’ This made Roche initiate infringement
proceedings against Cipla.
 Roche claimed that Cipla had infringed Patent in 774 also known as
‘Erlotinib Hydrochloride’ which is licensed to Roche.
 Roche lost the above suit as the Honorable court felt that stopping
Cipla’s manufacture would be against public interest and so the
balance of convenience was in Cipla’s favor.
 On appeal, the Division Bench upheld the decision but focused more
on the failure of Roche to establish a prima facie case of
infringement.
 The SLP filed by Roche against the decision was declined as well.
 The parties then returned to the single judge to the trial on main
relief; the judge delivered judgment and Roche could not sufficiently
prove that Cipla’s manufacture of Erlocip infringed its patent IN774.
 The case was then taken to the Division Bench where the case went
in favor of Roche.

Why Did It Go In Favor Of Roche?

Roche from the very beginning of the suit claimed that Erlocip is Erlotinib
Hydrochloride, but the claim for a patent made by Cipla was Polymorph B of
the compound Erlotinib Hydrochloride. On this, the Judge held that-

“Any process involved in making Polymorph B of Erlotinib Hydrochloride

would involve the preparation of Erlotinib Hydrochloride itself; in fact, a
perusal of US ‘221 reveals that it is clearly stated that Erlotinib Hydrochloride
in Polymorph B form results from re-crystallization of Erlotinib Hydrochloride
using different solvents and temperature conditions. Hence if the suit were
found to disclose Erlotinib Hydrochloride, any polymorphic version of the
same would infringe the suit patent as Erlotinib Hydrochloride itself would be
underlying every such polymorphic version.

The patent IN 774 stated that “this compound may exist in several
polymorphic forms, but any and all such forms will be subsumed within its
patent. Therefore Cipla’s Erlocip being a polymorphic form of Erlotinib
Hydrochloride it will most certainly infringe IN 774 of Roche.” With this, the
case went in favor of Roche.

Test For Infringement

The judgment laid down detailed steps and guidelines that should be followed
in every infringement of patent suit. They are as follows:

 Firstly, infringement is not proved by positive evidence which

includes the medical and clinical evaluation of a product by the
defendant company.
 Secondly, an infringement examination does not compare an
allegedly infringing product with the marketed product, but the
comparison is made with the claims of the patent itself.
 Thirdly, it was said that the correct test, in this case, is to map Cipla
product against Roche’s Patent claims.
So finally a 16 step test for constructing claims of a patent for the purpose of
determining its scope and find out whether there has been any infringement
was laid down. This can be treated as a standard and ideal for any patent
infringement suit.

The Judgement
The judgment finally went in favor of Roche. The guidelines applicable to
many crucial aspects of a patent infringement were clearly laid down in the
Judgement. Cipla was made liable to render accounts concerning
manufacture and sale of Erlocip and decreed costs in favor of Roche of Rs. 5,
00, 000. The Court did not, however, grant a permanent injunction on
manufactured by Cipla.

Conclusion
The Roche and Cipla Judgement surely laid down detailed guidelines in the
field of patent infringement, but the mindless following of standards is surely
something which cannot be done in the case of patents. Thus keeping the
map in mind every judgment has to reach its DESTINATION following its
road.